The American Society for Microbiology (ASM) is submitting the following statement in response to the Food and Drug Administration's Federal Register Notice of October 25, 1999 (Docket No. 99N-4282) requesting public comment on issues within the FDA's jurisdiction related to foods derived from plants developed using bioengineered techniques.

The American Society for Microbiology, which represents over 41,000 microbiologists worldwide, has a special interest in issues and policies related to biotechnology research and development. The ASM includes scientists working in academic, governmental and industrial institutions with expertise in molecular biology and genetics, environmental microbiology, medical microbiology and infectious diseases and agricultural and industrial microbiology, including the microbiology of food. ASM members pioneered molecular genetics and were principals in the discovery and application of recombinant DNA procedures which have advanced biotechnology's prominence. Moreover, ASM members have for several decades participated in discussions concerning biotechnology before federal agencies and Congress.

Since the inception of bioengineering in the 1970s, the ASM has examined safety issues associated with biotechnology and its applications. The ASM believes that oversight and regulation should be firmly based on scientific principles and practices. The ASM has long expressed the opinion that regulation would be based on risk associated with the products of biotechnology and not on the process used to create or to produce these products. The ASM participated, and some of its members provided leadership in the development of the NIH Guidelines for Recombinant DNA Research, which include sections applicable to working with plants. The ASM has a continuing working relationship with the U.S. Department of Agriculture and the Environmental Protection Agency, providing experts to advise on plant-microbe interactions, whether engineered or not. The ASM also has provided expertise to the FDA in assessing the safety of foods, including bioengineered products.

The ASM has advised repeatedly that policy regulating biotechnology should focus on organisms that pose significant risk. This is necessary not only to protect public health and the environment, but also to encourage continued biotechnological research and development, which is in the national interest. Indeed, the FDA is to be commended for constructing a framework for safety evaluation that is product based, and for taking the position "that the critical consideration in evaluating the safety of (bioengineered) foods should be the objective characteristics of the food product or its components rather than the fact that new development methods were used."

Benefits and Impact of Bioengineered Foods:

The ASM believes that most of the benefits of bioengineered foods are yet to be realized. While many processed foods contain bioengineered components, their availability, cost, taste and safety are not affected. An important product that consumers have a direct benefit from currently is cheese made with the use of a bioengineered enzyme that replaces the enzyme obtained from calves' stomachs. The availability of certain foods, such as the Hawaiian papaya, rests on bioengineering; plant viruses were killing the trees and fruit. In the research pipeline are foods that have lowered or no allergens, enhanced nutritional content such as vitamins and minerals, naturally decaffeinated coffee and food with medicinal benefits such as antioxidants and vaccines. Indirectly, consumers will benefit from plants that resist pests and pathogens that produce deleterious compounds such as aflatoxins, the most potent carcinogenic agents yet known. Such mycotoxins also cause pain and suffering to animals that consume them. Producers, including home gardeners, will be exposed to fewer synthetic pesticides. Such pesticides can adversely affect health, nontarget organisms and water quality. Bioengineered products are thoroughly evaluated for untoward safety effects for people and the environment, and such testing is expected to continue.

Scientific/Safety Issues:

The ASM is of the opinion that the FDA's consultation process has achieved its intended purpose and provided safe products for the marketplace. However, we support making consultation mandatory at this time. This would assure that all developers of bioengineered foods consult with the agency before marketing such foods, and reassure the public that the food it purchases has been subject without exception to FDA safety and regulatory procedures.

Newly emerging scientific information relating to the safety of foods is applicable to all products, bioengineered or otherwise, and should be used if and as needed to safeguard consumers. The ASM is unaware at this time of tests designed specifically for bioengineered food that would assure safety to a greater degree than the application to those foods of current FDA tests. The ASM suggests that the phasing out of the use of antibiotic resistance markers in plants should be encouraged as a positive measure. These markers are used in preliminary selection processes, and are not needed subsequently. Their elimination would remove all chances of transfer of an antibiotic resistant gene from a bioengineered food to bacteria that inhabit the digestive system of humans and other animals.

Food products planned for the future include foods with altered composition in oils, vitamins and minerals. Foods with reduced allergy potential, including chocolate, peanuts and rice, are being developed. Naturally decaffeinated coffee is under development. In addition, foods containing genes for traits conferring plant protection are also planned. The availability and modest cost of papaya from Hawaii is due to bioengineering and is a prototype of nonpesticidal protection for foods consumed directly by humans. The safety issues raised by these foods are no different in kind than those that have been developed over nearly a century of testing.

Public Information Issues:

The ASM believes that labeling should be on the basis of significant alterations in the composition of the food rather than the process by which it is produced. Bioengineered techniques are essentially refinements of the methods of genetic modification that have long been used to enhance plants and animals for food. Because of the improved precision and predictability of bioengineering techniques, it can be anticipated that in the future food will be more, rather than less safe. Added genes do not themselves increase the risk of toxicity or allergenicity. Added genes are DNA, which is compositionally, the same DNA as other genes. Concern for safety arises only when genes are expressed in the form of proteins that are toxic or evoke allergic reactions. Bioengineered products should be, and indeed are, tested for toxins and allergens by FDA standards to the same extent products of conventional manufacture are tested. The FDA's 1992 policy statement defines certain safety related characteristics of new foods that if present and detected would require special agency attention that could result in additional testing and labeling. Included are substances new to the food that may be toxic or allergenic. Current FDA policy and procedures result in regulatory scrutiny that is commensurate with risk. This is a position the ASM supports and believes should be maintained. Food labeling is justified if it identifies real risk and provides information relevant to the safety of consumers. To label a product simply because it is bioengineered would not provide useful information about the safety of the food.

The ASM strongly supports programs in science education for the public, and encourages the FDA to increase public information about bioengineered plants and other products. It is important for the public to understand just what bioengineering entails as well as its history and various applications in agriculture, the environment and medicine. Familiarity will diminish fear, and knowledge will result in informed choice. The FDA and USDA should jointly design and conduct a program of education using conventional publication techniques as well as a web site. The initiative will require more funding than is likely to be available presently. However, the FDA could solicit nongovernmental organizations, such as health networks and professional societies, to assist in disseminating information to the public.

In closing, the ASM would like to emphasize to the Administration and Congress the critical role of the Food and Drug Administration and the importance of providing the agency with adequate resources to accomplish its mission of protecting the public health.